- Nano cap Capricor Therapeutics (NASDAQ:CAPR) is up 34% premarket on modestly higher volume in response to its announcement that the FDA has approved its IND to conduct a new clinical trial, HOPE-2, assessing CAP-1002 in boys and young men with Duchenne muscular dystrophy (DMD).
- If successful, the data will support a U.S. marketing application. The trial should be initiated next quarter.
- HOPE-2 will enroll ~84 subjects. The primary endpoint will be the change from baseline in the mid-level dimension of the Performance of the Upper Limb test at month 12.
- CAP-1002 is an investigational allogeneic, off-the-shelf cardiac cell therapy derived from donor heart tissue and infused directly into the patient's coronary artery via a catheter.
- Management will host a conference call today at 4:30 pm ET to discuss the study.
- Previously: Capricor announces positive 12-month data on DMD candidate CAP-1002; investors unmoved, shares down 12% (Nov. 15)
- Now read: Capricor: Risks Outweigh 'HOPE'
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